FDA Inspection
Zepf Surgical Instruments Inc.Zepf Surgical Instruments Inc. – FDA Inspection, Sep 2, 2015
Record Details
This FDA Inspection record concerns Zepf Surgical Instruments Inc., with an inspection on September 2, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- September 2, 2015
- Product Type
- Devices
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ID · dc571a59-6077-4dcb-b462-77123170dd66
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 941274
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.198(a)Complaints
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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